Catheter With Imaging Assembly With Placement Aid And Related Methods Therefor

ABSTRACT

A feeding tube assembly having a feeding tube, an imaging assembly having a rigid axis and a bending axis transversely oriented relative to the rigid axis is disclosed. The imaging assembly can be preferentially deformable along the bending axis relative to the rigid axis. A marking disposed on at least one of the imaging assembly and the feeding tube can provide an indication of the bending axis. A packaging comprising a curvilinear cavity and a circular cavity can respectively contain the imaging assembly and the feeding tube, in a coiled configuration, which induces the feeding tube assembly into a pre-set, arcuate shape.

BACKGROUND

Several medical procedures involve positioning a catheter, such as a feeding tube or endoscope, within a patient through the patient's nose, mouth, or other opening. In many procedures, accurately positioning the catheter is crucial to the success of the procedure and/or to the safety of the patient. For example, a nasogastric (NG) feeding tube may be inserted through the nose, past the throat, and down into the stomach, or past the stomach into the small bowels of the patient to deliver food to the patient via the tube. If the feeding tube is mistakenly positioned in the patient's lung, the feeding solution would be delivered to the patient's lung causing critical and possibly fatal results.

Accordingly, x-ray imaging devices and procedures have been used to confirm accurate positioning of a feeding tube, or other type of catheter, within a patient. Specifically, x-ray images are taken of the patient after a feeding tube has been initially positioned within the patient. The x-ray images are examined to determine whether the feeding tube was properly positioned or whether re-positioning is necessary. The x-ray imaging procedure is repeated until feeding tube has been properly positioned. Part of the challenge of proper insertion is navigating the various turns within the body. For nasogastric feeding tubes, a sharp turn is required at the nasopharynx.

These x-ray imaging procedures are generally expensive and time consuming. Additionally, a patient often uses a feeding tube for a substantial length of time. Thus, the x-ray imaging procedures must be repeated periodically to ensure that the feeding tube has not moved (i.e., migrated). Repeated exposure to x-ray radiation is not preferred.

SUMMARY

One or more aspects of the present invention can pertain to a feeding tube assembly having a feeding outlet for delivering enteral feeding liquid. The feeding tube assembly can comprise a feeding tube having opposite first and second longitudinal ends, and a feeding passage extending along a longitudinal axis defined between the first and second longitudinal ends of the feeding tube; an imaging assembly secured to the feeding tube proximate the first longitudinal end of the feeding tube, the imaging assembly having a rigid axis and a bending axis transversely oriented relative to the rigid axis, wherein the imaging assembly can be preferentially deformable along the bending axis relative to the rigid axis; and a marking disposed proximate the first longitudinal end on at least one of the imaging assembly and the feeding tube, wherein the marking can be configured to provide an indication of the bending axis. In one or more embodiments pertinent to one or more aspects of the invention, the imaging assembly can comprise a deformable circuit element that is preferentially deformable with the bending axis relative to the rigid axis, and an imaging device mounted on the deformable circuit element. In one or more embodiments pertinent to one or more aspects of the invention, the imaging assembly can further comprise a light source and housing enclosing the deformable circuit element, the imaging device, and the light source, wherein the marking is disposed on an outer surface of the housing. In one or more embodiments pertinent to one or more aspects of the invention, the deformable circuit element can comprise a planar longitudinal portion planarly oriented parallel to the longitudinal axis of the feeding tube, and a planar transverse portion transversely oriented relative to the longitudinal axis of the feeding tube, wherein the deformable circuit element can be preferentially bendable along the planar longitudinal portion, and wherein the imaging device and the light source are mounted on the transverse portion of the deformable circuit element. In one or more embodiments pertinent to one or more aspects of the invention, the deformable circuit can comprise a planar longitudinal portion and at least one fold line on the planar longitudinal portion oriented transversely relative to the longitudinal axis of the feeding tube.

One or more aspects of the invention can pertain to a feeding tube kit. The kit can comprise a feeding tube assembly including a flexible feeding tube having opposite first and second longitudinal ends, a longitudinal axis extending between the first and second longitudinal ends, and a feeding passage defined therein extending along the longitudinal axis between the first and second longitudinal ends, an inlet adaptor adjacent the second longitudinal end of the tube in fluid communication with the feeding passage, the inlet adaptor configured for fluid connection to a source of enteral feeding liquid to fluidly connect the source of enteral feeding liquid to the feeding passage, an elongate imaging assembly including an imaging device, the imaging assembly configured for generating and transmitting imaging signals indicative of images of the alimentary canal of a subject, wherein the imaging assembly has a longitudinal axis and is secured to the tube adjacent the first longitudinal end of the tube, the imaging assembly being bendable along its longitudinal axis in a bending direction, and a feeding outlet proximate the imaging assembly and in fluid communication with the feeding passage for delivering enteral feeding liquid to the subject; and a package in which the feeding tube assembly is received, the package including an imaging assembly cavity having an elongate, curvilinear shape selected to pre-form a desired bend into the imaging device, wherein the imaging assembly is received in the imaging assembly cavity so that the imaging assembly conforms generally to the curvilinear shape of the imaging assembly cavity. In one or more embodiments pertinent to one or more aspects of the invention, the imaging assembly cavity includes opposing, curvilinear side walls engaging the imaging assembly. In one or more embodiments pertinent to one or more aspects of the invention, the imaging assembly is generally non-bendable along its longitudinal axis in a transverse direction that is generally transverse to the bending direction, wherein the feeding tube assembly further includes a marking on one of the imaging assembly, and the feeding tube generally adjacent the first longitudinal end of the feeding tube, the marking configured for indicating at least one of the bending direction of the imaging assembly. In one or more embodiments pertinent to one or more aspects of the invention, the marking is aligned with the packaging to orient the imaging assembly in the imaging assembly cavity. In one or more embodiments pertinent to one or more aspects of the invention, the imaging assembly is configured to fully or partially retain the conformed curvilinear shape. In one or more embodiments pertinent to one or more aspects of the invention, the feeding tube assembly includes a marking that is aligned with the packaging so as to orient the imaging assembly in the imaging assembly cavity to pre-set a shape in the imaging assembly for traversing the nasopharynx. In one or more embodiments pertinent to one or more aspects of the invention, the package includes a feeding tube receiving cavity, wherein the feeding tube is coiled and received in the feeding tube receiving cavity.

One or more aspects of the invention can pertain to a method of providing a feeding tube assembly having a feeding passage and a feeding outlet for delivering enteral feeding liquid. The method can comprise providing a feeding tube having an imaging assembly secured to the feeding tube proximate the feeding outlet of the feeding tube, the imaging assembly having a rigid axis and a bending axis that is transversely oriented relative to the rigid axis, wherein the imaging assembly is preferentially deformable along the bending axis relative to the rigid axis; providing a container comprising an curvilinear cavity and a receiving cavity; and arcuately disposing at least a portion of the imaging assembly in the curvilinear cavity in conformation with the bending axis of the imaging assembly. In one or more embodiments pertinent to some aspects of the invention, the method can further comprise coiling at least a portion of the feeding tube in a plurality of loops, wherein each of the loops having a coiling direction at least partially coincident the bending axis, and disposing the loops in the receiving cavity. In one or more embodiments pertinent to some aspects of the invention, the feeding tube assembly can further comprise a marking disposed on at least one of the imaging assembly and the feeding tube, wherein the marking is configured to provide an indication of the bending axis. In one or more embodiments pertinent to some aspects of the invention, the method can further comprise disposing a stylet in the feeding passage before coiling the at least a portion of the feeding tube.

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

Other features will be in part apparent and in part pointed out hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration showing a perspective view of an imaging feeding tube assembly, in accordance with one or more aspects of the invention;

FIG. 2 is schematic illustration showing an exploded perspective view of the feeding tube assembly in FIG. 1, in accordance with one or more aspects of the invention;

FIG. 3 is a schematic illustration showing a side, elevational view of an imaging feeding tube system, including the imaging feeding tube assembly in FIG. 1, and interface cable, and a console, in accordance with one or more aspects of the invention;

FIG. 4A is schematic illustration showing a perspective view of a console connector of the feeding tube assembly in FIG. 1, showing internal components and including feeding tube segments of a feeding tube, in accordance with one or more aspects of the invention;

FIG. 4B is a schematic illustration showing another embodiment of an inlet adaptor for the imaging feeding tube assembly, in accordance with one or more aspects of the invention;

FIG. 5 is a schematic illustration showing an enlarged, fragmentary, perspective view of a distal end portion of the feeding tube assembly in FIG. 1, including an exploded imaging assembly, an imaging assembly connector, and a portion of the feeding tube, in accordance with one or more aspects of the invention;

FIG. 6 is a schematic illustration showing an enlarged cross section view of the feeding tube of the feeding tube assembly in FIG. 1, in accordance with one or more aspects of the invention;

FIG. 7 is a schematic illustration showing a top perspective view of a flex circuit assembly of the imaging assembly in FIG. 5, in a folded configuration, in accordance with one or more aspects of the invention;

FIG. 8 is a schematic illustration showing a bottom perspective view of the flex circuit assembly of the imaging assembly in FIG. 4, in the folded configuration, in accordance with one or more aspects of the invention;

FIG. 9 is a schematic illustration showing a fragmentary view of the imaging assembly in FIG. 5, in accordance with one or more aspects of the invention;

FIG. 10 is a schematic illustration showing a perspective view of a cap of the imaging assembly in FIG. 5, in accordance with one or more aspects of the invention;

FIG. 11 is a block diagram of the flex circuit assembly in FIG. 7, in accordance with one or more aspects of the invention;

FIGS. 12 and 13 are circuit schematic illustrations of the flex circuit embodiment in FIG. 11, in accordance with one or more aspects of the invention;

FIG. 14 is a schematic illustration showing a top plan view of the flex circuit assembly of the imaging assembly in FIG. 7, in an unfolded configuration, in accordance with one or more aspects of the invention;

FIG. 15 is a schematic illustration showing a top view of a first substrate of the flex circuit assembly in FIG. 14, in accordance with one or more aspects of the invention;

FIG. 16 is a block diagram of the flex circuit assembly, in accordance with one or more aspects of the invention;

FIG. 17 is a block diagram of the flex circuit assembly, in accordance with one or more aspects of the invention;

FIG. 18 is a block diagram of an exemplary feeding tube system, in accordance with one or more aspects of the invention;

FIG. 19 is a flow diagram showing an exemplary graphical user interface screen flow, in accordance with one or more aspects of the invention;

FIGS. 20-31 are schematic illustrations showing exemplary graphical user interface screens displayable by a console, in accordance with one or more aspects of the invention;

FIG. 32A is a schematic illustration showing a perspective view of an imaging feeding tube assembly, in accordance with one or more aspects of the invention;

FIG. 32B is a schematic illustration showing an exploded perspective of the imaging feeding tube assembly in FIG. 32A, in accordance with one or more aspects of the invention;

FIG. 33 is a schematic illustration showing a cross-sectional view of a feeding tube of the imaging feeding tube assembly in FIG. 32A, in accordance with one or more aspects of the invention;

FIG. 34 is a schematic illustration showing an exploded perspective view of an imaging assembly of the imaging feeding tube assembly in FIG. 32A, in accordance with one or more aspects of the invention;

FIG. 35 is a schematic illustration showing a perspective view of a rigid-flex circuit assembly, in accordance with one or more aspects of the invention;

FIG. 36 is a schematic illustration showing a top plan view of a rigid-flex circuit, in accordance with one or more aspects of the invention;

FIG. 37 is a schematic illustration showing a side, elevational view of a rigid-flex circuit, in accordance with one or more aspects of the invention;

FIG. 38 is a schematic illustration showing a perspective view of an imaging assembly connector of the imaging feeding tube assembly in FIG. 32A, in accordance with one or more aspects of the invention;

FIG. 39 is a schematic illustration showing a perspective view of the imaging assembly in FIG. 34, with a housing removed therefrom to show internal components, in accordance with one or more aspects of the invention;

FIG. 40 is a schematic illustration showing a longitudinal section view of the housing of the imaging assembly in FIG. 34, in accordance with one or more aspects of the invention;

FIG. 41 is a schematic illustration showing an imaging assembly, in accordance with one or more aspects of the invention;

FIG. 42 is a schematic illustration showing a cross-sectional view of a console connector of the imaging feeding tube assembly, in accordance with one or more aspects of the invention;

FIG. 43 is a schematic illustration showing an interface cable, in accordance with one or more aspects of the invention;

FIG. 44 is a schematic illustration showing a perspective view of a flex circuit assembly, with a flex circuit in a folded configuration, in accordance with one or more aspects of the invention;

FIG. 45 is a schematic illustration showing a perspective view of the flex circuit in FIG. 44 in an unfolded or flat configuration, in accordance with one or more aspects of the invention;

FIG. 46 is schematic illustration showing a top plan view of the catheter, the catheter including a marking, in accordance with one or more aspects of the invention;

FIG. 47 is a schematic illustration showing a fragmentary perspective view of a distal end portion of the catheter in FIG. 46, with the imaging assembly having a bent or arcuate shape, in accordance with one or more aspects of the invention;

FIG. 48 is a schematic illustration showing a front elevational view of a feeding tube assembly packaging, a package of the packaging being transparent to show a feeding tube assembly received in the package; and

FIG. 49 is a schematic illustration showing a top plan view of the feeding tube assembly packaging of FIG. 48, with a lid of the package being removed.

Corresponding reference characters indicate corresponding parts throughout the drawings.

DETAILED DESCRIPTION

Referring to the drawings, and in particular to FIGS. 1-3, an imaging catheter is generally indicated at 10. As disclosed herein, the imaging catheter can be a medical device that is configured for insertion into a subject (e.g., a human or a non-human subject) and configured to provide images (e.g., digital video) of anatomy of the subject as the medical device is inserted into the subject and/or after the medical device is positioned in the subject. In the illustrated embodiment, the imaging catheter is configured as a feeding tube assembly 10 and exemplarily illustrated as a nasogastric feeding tube assembly. In general, the illustrated nasogastric feeding tube assembly 10 can be configured to provide digital images of an alimentary canal, or a portion(s) thereof, of the subject as the feeding tube assembly is inserted into the subject and after the feeding tube assembly is positioned in the subject to facilitate confirmation of proper placement of the feeding tube assembly in the subject. The nasogastric feeding tube assembly 10 can be also configured to deliver liquid nutrients into the alimentary canal of the subject by enteral feeding, such as after a user (e.g., medical practitioner) confirms proper placement of the feeding tube assembly in the subject, by viewing the acquired digital images from the imaging feeding tube assembly. It is understood that the imaging catheter 10 may be configured as a different type of feeding tube, such as a gastric feeding tube, or a jejunostomy feeding tube, or may be configured as a different type of medical device, such as an endoscope, or a heart catheter (e.g., balloon catheter or other type of heart catheter).

The illustrated feeding tube assembly 10 generally includes an elongate, generally flexible body in the form of a feeding tube, generally indicated at 12, having a longitudinal axis A (FIG. 6), an open first longitudinal end (i.e., a distal end) and an open second longitudinal end (i.e., a proximal end). A feeding passage 14 (FIGS. 4-6), defined by an interior surface of the feeding tube 12, extends longitudinally between the longitudinal ends of the tube for delivering nutrients (e.g., in the form of an enteral feeding solution) to the subject. In other embodiments—such as catheters that are not feeding tubes—the elongate body may have other configurations, and may not have a longitudinal passage for delivering fluids to the patient. An inlet adapter, generally indicated at 16, for delivering liquid nutrients into the feeding passage 14 is attached to the second end of the tube, and an imaging assembly, generally indicated at 18, for generating and transmitting real time images (e.g., video) of the alimentary canal of the patient during and/or following intubation is attached to the first end of the tube 12 by an imaging assembly connector, generally indicated at 20. As used herein with the point of reference being the feeding source, the inlet adaptor 16 defines the proximal end of the feeding tube assembly 10, and the imaging assembly 18 defines the distal end. The feeding tube assembly 10 also can include a console connector, generally indicated at 22, in communication with the imaging assembly 18, to provide communication between the imaging assembly and a console 23 (FIG. 3), on which the images obtained by the imaging assembly 18 may be displayed, as described in detail herein. In the illustrated embodiment, the feeding tube assembly 10, the console 23, and an interface cable 242, which communicatively connects the feeding tube assembly to the console, together constitutes an imaging catheter system, and more specifically, an imaging feeding tube system.

Referring to FIGS. 1-4, the exemplarily illustrated feeding tube 12 comprises two tube segments: a first tube segment 12 a extending between the imaging assembly connector 20 and the console connector 22, and a second tube segment 12 b extending between the console connector and the inlet adaptor 16. As disclosed in more detail below, the first and second tube segments 12 a, 12 b can be secured to the console connector 22 in such a way that the first and second tube segments are in fluid communication with each other to at least partially define the feeding passage 14. In other embodiments of the invention, the tube 12 may be formed as an integral, one-piece component.

The tube 12 may comprise indicia such as graduations (not shown) that show or providing a relative indication of insertion depth to facilitate proper intubation. In one example, the tube 12 may have a length between about 36 inches and about 55 inches, although it may be of other lengths without departing from the scope of the invention.

As shown in FIG. 6, the first tube segment 12 a typically includes one or more electrical conductors 24 (broadly, a signal-transmitting component) typically disposed in the tube wall of the first tube segment. The second tube segment 12 b may be free from such electrical conductors. The electrical conductors 24 of the first tube segment 12 a run longitudinally along the first tube segment, such as along or parallel a longitudinal axis of the feeding passage 14. At least some of the electrical conductors 24 can be configured to transmit imaging signals between the imaging assembly 18 and the console 23, such as through the console connector 22 and the interface cable 242. Other electrical conductors 24 may be configured to transmit power from the console 23 to the imaging assembly 18, and provide a ground. Still other electrical conductors 24 may be configured to provide other communication including, but not limited to, two-way communication, between the console 23 and the imaging assembly 18. The first tube segment 12 a may include a different type of a signal-transmitting component, such as fiber-optic cables or other signal-transmitting components, to effect transmission of signals between the imaging assembly 18 and the console connector 22. In one or more embodiments of the invention, at least one of the electrical conductors 24 is configured to supply power from a power supply, which can be the console 23, to the imaging assembly 18, although other ways of powering the imaging assembly, including the imaging assembly having its own source of power, do not depart from the scope of the present invention.

As exemplarily illustrated, the electrical conductors 24 can be disposed within a conductor passage 26 of the feeding tube 12 so that the conductors are physically separated or at least fluidly isolated from the feeding passage 14 to inhibit or reduce the likelihood of feeding solution in the feeding passage from contacting the conductors. As shown in FIG. 6, the interior surface defining a portion of the feeding passage 14 in the first tube segment 12 a has a generally circular cross section having an arcuate portion 28 extending inwardly and running longitudinally along a lengthwise dimension of the feeding tube assembly or segment. The electrical conductors 24 can be disposed within the tube wall of the first tube segment 12 a between the arcuate portion 28 of the interior surface and the exterior surface of the tube segment which provides a configuration that allows physical separation between the electrical conductors 24 and the enteral feeding solution in the feeding passage 14, as disclosed above, and can maximize the area or volume of the feeding passage. A longitudinal axis A passes through the feeding passage 14. As such, this configuration promotes the flow of fluid in the feeding passage 14 and reduces the likelihood of occlusions in the feeding passage. A substantially uniform wall thickness around passage 14, as shown in FIG. 5, can decrease the amount of material entrapment that may occur, or at least can reduce the likelihood of formation of occlusions. It is understood that the first tube segment 12 a may be of other configurations without departing from the scope of the present invention.

The feeding tube 12, including, for example, the first and second tube segments 12 a, 12 b, may be formed from a thermoplastic polyurethane polymer, such as but not limited to, an aromatic, polyether-based thermoplastic polyurethane, and a radiopaque substance, such as barium. The first and second tube segments 12 a, 12 b may be formed by an extrusion process. The tube 12 may be formed from other materials and may be formed in other ways without departing from the scope of the present invention. In one non-limiting example, the electrical conductors 24 (or other signal-transmitting components) may be co-extruded with the first tube segment 12 a to embed the conductors in the first tube segment. In another example, the conductors 24 (or other signal-transmitting components) may be fed through the conductor passage 26 after forming the first tube segment 12 a. Introducing any of the one or more conductors 12 can be facilitated by, for example, internally pressurizing passage 26 with a fluid prior to insertion therein. Other ways of forming the first tube segment 12 a and/or the tube 12 do not depart from the scope of the present invention.

Referring back further to FIGS. 1 and 2, the illustrated inlet adaptor 16 typically includes first and second inlet ports 30, 32, respectively, in fluid communication with a single outlet port 34. The exemplarily illustrated inlet adaptor 16 may be referred to as a Y-port. The first inlet port 30 may be used for connection to a source of liquid nutrients, such as an enteral feeding solution. For example, a barbed connector (not shown), in fluid communication with the source of an enteral feeding solution, may be inserted into the first inlet port 30 and secured therein by a friction-fit. Thus an aspect of the present invention may involve configurations with the feeding fluid in fluid communication with the feeding tube assembly. An optional cap 35 tethered on the inlet adaptor 16 can be removably receivable in the first inlet port 30 to close the inlet port when it is not being used. The second inlet port 32 may be used for connection to a source of medicine. Optional tethered first and second caps 36, 37, respectively, can be used to variably configure the second inlet port 32 as a connection or port to various or different connectors typically used with various sources of medicine. For example, the first cap 36 can be removably receivable in the second inlet port 32, providing a central opening therethrough that is sized and shaped to mate with a catheter syringe. The second cap 37 can be removably receivable in the central opening in the first cap 36, thereby providing a central opening that is sized and shaped to particularly mate with a tip of an oral syringe. The inlet adaptor 16 may take on other shapes, sizes and configurations, or may be entirely omitted, without departing from the scope of the invention.

The inlet adaptor 16 can be secured to the second or proximal end of the tube 12 at an adaptor weld, generally indicated at 38, so that the outlet port 34 of the adaptor 16 is in sealed fluid communication with the feeding passage 14 of the feeding tube. The adaptor weld 38 typically tapers distally from the adaptor 16 to the tube 12 so that the weld has a smooth, generally continuously decreasing diameter. It is to be understood that the adaptor 16 may be secured to the tube 12 in other ways without departing from the scope of the invention. For example, the inlet adaptor 16 may be secured to the tube 12 by solvent bonding, or other securement techniques. The adaptor 16 may be composed of the same material as the feeding tube 12, or a blend of materials, or a different but compatible material. In one example, the adaptor 16 is composed of a blend of polyvinyl chloride and polyurethane elastomer. In another example, the adaptor 16 is composed of an aromatic, polyether-based thermoplastic polyurethane or DEHP-free PVC. The adaptor 16 may be formed from other types of materials within the scope of the invention.

Referring to FIGS. 1, 2, and 5, the imaging assembly connector 20 can have a first end margin, such as a distal end margin, secured to the imaging assembly 18, and a second end margin, such as a proximal end margin, secured to the first end margin of the first tube segment 12 a. The imaging assembly connector 20 typically defines a feeding outlet 40 that is in fluid communication with the feeding passage 14 of the tube 12. The feeding outlet 40 can comprise one or more openings extending laterally through a side of the imaging assembly connector 20 (only one such lateral opening is illustrated). In the illustrated embodiment, the first or distal end of the tube 12 is received and secured within the imaging assembly connector 20 at the second or proximal end of the imaging assembly connector to provide fluid communication between the feeding passage 14 and the feeding outlet 40. The imaging assembly connector 20 can be closed adjacent the first or distal end to prevent the feeding solution in the feeding passage 14 from entering the imaging assembly 18. Thus, the imaging assembly 18 is typically sealed off from and not in fluid communication with the feeding passage 14. Instead, the feeding solution typically flows laterally out from the outlet 40 relative to the feeding tube 12. When the feeding tube assembly 10 is determined to be appropriately positioned in a patient, feeding solution or other desirable liquid fed into the inlet adaptor 16 can be introduced through the feeding passage 14 of the tube 12, and out through the outlet 40 and into the subject's alimentary canal. As illustrated in FIG. 5, the first end margin of the imaging assembly connector 20 can have a connection portion 42 shaped and sized to fit in the imaging assembly 18. The imaging assembly connector 20 may be formed integrally with the imaging assembly 18 or may be omitted, without departing from the scope of the present invention.

The electrical conductors 24 may be embedded or otherwise received in the wall of the imaging assembly connector 20 so that the conductors are sealed from the feeding outlet 40 and the feeding passage 14 to inhibit feeding solution from contacting the conductors. In one embodiment, the imaging assembly connector 20 may include two distinct parts that are assembled together. The first part may define the feeding outlet 40 that receives liquid from the tube 12, as described above, and a conductor passage (not shown) that is separate and apart from the feeding passage outlet. The second part may define the connection portion 42 and a conductor passage extending to a conductor passage in the first part to facilitate connection of or carry the electrical conductors 24 between the imaging assembly 18 and the tube 12. The imaging assembly connector 20 may take on other shapes, sizes and configurations (or may be entirely omitted) without departing from the scope of the invention. Moreover, the imaging assembly 18 may be secured to the tube 12 in other ways without departing from the scope of the present invention.

In one example, the imaging assembly connector 20 may be injection molded onto the end of the feeding tube 12. The direct connection of the imaging assembly connector 20 to the feeding tube provides strain relief for the electrical conductors 24 extending out of the end of the feeding tube 12 to the imaging assembly.

Referring to FIG. 5, the imaging assembly 18 can include a tubular housing 50, a flexible circuit (“flex circuit”) assembly 60 disposed within the tubular housing, and a transparent or translucent cap 70 secured to the tubular housing 50. Generally, a flex circuit includes a deformable circuit element and components mounted on the deformable circuit element. The deformable circuit element may be a flat (at least prior to being deformed) substrate that can be bent or otherwise deformed, and which also includes electrical conductors for making electrical connection among various components that may be mounted on the substrate. The deformable circuit element may only be partially deformable (e.g., only at discrete bend lines) within the scope of the present invention. In some configurations, the deformable circuit element may have one or more bend lines that facilitate preferential deformation of the flex circuit and, in some cases, the imaging assembly, typically transversely or orthogonally relative to the bend lines. Among other functions, the tubular housing 50 can provide protection for the flex circuit assembly 60, and the housing may be substantially waterproof to inhibit the ingress of liquid into the imaging assembly 18. The tubular housing 50 has an interior surface defining an axial passage 52 shaped and sized for housing the flex circuit assembly 60 in a folded configuration. In one embodiment, the tubular housing 50 is formed from a generally flexible material that provides protection for the flex circuit assembly 60 and allows the imaging assembly 18 to bend to facilitate maneuverability of the feeding tube assembly 10. A second end, such as a proximal end, of the tubular housing 50 can be configured to receive the connection portion 42 of the imaging assembly connector 20, and can be adhered thereto to secure the imaging assembly to feeding tube 12. The tubular housing 50 may be generally opaque, by being formed from an opaque white material or having an opaque material applied thereon, to reflect illumination from a light source, such as an internal LED 96, and direct the illumination outward from the distal end of the imaging assembly 18 to, for example, a field of view.

The flex circuit assembly 60 typically includes a flex circuit 80 and electronic components (not labeled), described below, attached thereto. In general, the flex circuit 80 may include a generally flat, planar portion that is generally bendable out-of-plane along its length, and is generally unbendable (i.e., rigid) in-plane along its length. Accordingly, as shown in FIGS. 5 and 8, the imaging assembly 18 is generally bendable relative to its longitudinal axis LA1 in opposite first and second bending directions A1, A2 (i.e., within a bending plane), such as along a bending axis, that is transverse to the longitudinal axis of the flex circuit assembly, and is generally unbendable or rigid in opposite third and fourth transverse directions A3, A4 (i.e., within a rigid plane), such as along a rigid axis, that is generally transverse to the both the first and second bending directions and the longitudinal axis of the flex circuit assembly. As set forth above, the ability of the imaging assembly 18 to bend facilitates maneuverability of the feeding tube assembly 10. Further configurations contemplate an imaging assembly having a bending axis along which the imaging assembly preferentially arcuately deforms relative to any rigid axis thereof. Some aspects of the invention can thus be directed to an imaging assembly 18 that may be preferentially arcuately deformed along its length, along a preferred bending axis thereof, to facilitate insertion of the feeding tube assembly through the curvature of the nasopharynx. Some aspects of the present invention can involve utilizing an imaging assembly that may be flexibly bent to a curvilinear shape prior to entering the nasopharynx and/or may be capable of bending during nasopharynx insertion procedures. Accordingly, the rotational orientation of the imaging assembly 18 relative to the patient's anatomy, e.g., the nasopharynx, may be advantageously utilized because the imaging assembly has preferential a curvilinear shape or is capable of preferentially bending or arcuately deforming in only a single plane, or bi-directionally along a bending axis.

In one embodiment (FIGS. 46 and 47), the catheter 10 can comprise at least one indicia, such as a marking 62, for indicating the preferred curvilinear shape, the bending direction(s) or bending plane of the imaging assembly 18 and/or indicating a proper rotational orientation of the imaging assembly during insertion of the catheter. For example, in the illustrated embodiment the marking 62 may comprise an arrow. In one embodiment, the arrow 62 indicates to the user the location of the bending plane or bending directions A1, A2 to allow the user to bend the imaging assembly 18 into a curvilinear shape prior to insertion into the patient's nostril. Moreover, during insertion of the catheter 10 into the nasal passage of the patient, the user may orientate the catheter so that the arrow 62 is in the superior orientation relative to the patient. The marking 62 may include an additional arrow (not shown) that is diametrically opposite the illustrated arrow so that the additional arrow is in an interior position relative to the illustrated arrow when the catheter is properly orientated relative to the patient. The proper orientation will allow the imaging assembly 18, which may be pre-bent into the curvilinear shape to assume a pre-set or set shape, to conform generally to the shape of the nasopharynx. For example, visually aligning the marking on the imaging assembly will facilitate preferential deformation in the direction A2 as the imaging assembly enters the nasopharynx. The marking 62 may be located a predetermined distance d from the distal end of the catheter 10 (FIG. 46). This distance d may be slightly greater than an estimated distance from the entrance of the nostril to the nasopharynx so that prior to or as the imaging assembly 18 is entering the nasopharynx, the marking 62 is visible to the user and adjacent the patient so that the user can confirm that the marking is in the superior orientation and the imaging assembly is in the correct rotational orientation. The marking 62 may be of other configurations for indicating the bending direction(s) or bending plane of the imaging assembly 18 and/or indicating a proper rotational orientation of the imaging assembly 18 during insertion of the catheter.

In the partially assembled or folded configuration exemplarily shown in FIGS. 5, 7, and 8, the flex circuit assembly 60 can have a length with a first longitudinal end, e.g., a distal end, and an opposite second longitudinal end, e.g., a proximal end. The electrical conductors 24 can be connected to the second longitudinal end, e.g., the proximal end, of the flex circuit assembly 60. A camera mounting portion 82 is typically disposed at the first longitudinal end, e.g., the distal end of the flex circuit assembly 60. An imaging device such as a digital camera, generally indicated at 84, can be mounted on the camera mounting portion 82. The camera 84 can have a cuboidal shaped housing 86 with a base 86A, as shown in FIG. 8, sides 86B, 86C, 86D, 86E, and an upper or first surface 86F. The upper surface 86F of the camera 84 can include a lens 88. The lens 88 defines a field of view that projects generally outward from the distal end of the imaging assembly 18. In accordance with one or more embodiments of the invention, the camera 84 comprises an imaging device, such as a CMOS imaging device. In further embodiments of the invention, the camera 84 may comprise a different type of solid state imaging device, such as a charge-coupled device (CCD), or another type of imaging device. Other ways of configuring the electronics and other components of the imaging assembly 18 do not depart from the scope of the present invention and may be implemented as variant embodiments thereof. For example, in another embodiment, the flex circuit assembly 60 may be replaced with a rigid printed circuit board (PCB).

The flex circuit assembly 60 can include a power mounting portion 90 (FIGS. 5 and 7) and a control or data mounting portion 92 (FIG. 8) each typically extending from the camera mounting portion 82 at a fold line toward the first longitudinal end of the flex circuit assembly 60. In the illustrated embodiment, the data mounting portion 92 generally corresponds to the generally planar portion of the flex circuit assembly 60 that is bendable out-of-plane, as described above. As will be described in further detail, power supply components are typically disposed on the power mounting portion 90, and camera control components are typically disposed on the data mounting portion 92.

Referring to FIGS. 7 and 9, a light mounting portion 94 of the flex circuit 60 can be disposed at the side 86C of the camera 84. The light mounting portion 94 is illustratively depicted as extending longitudinally toward the camera 84 from a lateral side edge of the flex circuit at a fold line of the power mounting portion 90. One or more light sources 96 can be disposed on, for example, the light mounting portion 94 for illuminating an area or region adjacent to the upper surface 86F of the camera housing 86. In the illustrated embodiment, the light source is a light emitting diode (LED) 96 disposed on the light mounting portion 94 so that the LED is disposed on the side 86C of the camera housing and below or proximate the upper surface 86F of the camera housing. In the illustrated embodiment, the LED 96 has a light emitting surface 98 substantially perpendicular to the light mounting portion 94 for projecting light outward from the distal end of the imaging assembly 18. According to the illustrated embodiment (FIG. 9), the LED 96 and the light mounting portion 94 are positioned relative to the camera 84 and the camera mounting portion 82 such that the light emitting surface 98 of the LED 96 is a relatively short distance (e.g., 0.408 millimeters) below the upper surface 86F of the camera housing 86. Typically, LED 96 has an illumination zone that is at least partially coincident over an imaging zone or field of view of camera 84, through optional lens 88.

In another embodiment, one or more LEDs may be located distal of the camera. As shown in FIG. 44, one example of flex circuit assembly is generally indicated at reference numeral 60′. As illustrated in a folded or at least partially assembled configuration, a flex circuit 80′ of the flex circuit assembly 60′ can include an electrical component mounting portion 90′, a camera mounting portion 82′ on which a camera 84′ is mounted, and an LED mounting portion 94′ on which one or more light sources, such as four illustrated LEDs 96′, can be mounted. The LED mounting portion 94′ is typically configured to rest on an upper surface of the camera 84′ so that the LEDs 96′ are distal or offset from the camera. The LED mounting portion 94′ can include an opening 95′ aligned with the camera lens (not shown) so that the LED mounting portion 94′ does not obstruct the field of view of the camera 84′. FIG. 45 shows the flex circuit 80′ in the unfolded or flat configuration. The flex circuit may have other configurations and provide alternative locations for mounting of the camera and the light source.

Referring to FIGS. 9 and 10, the camera 84 and the LED 96 are illustratively shown as disposed in the optically transparent cap 70. The cap 70 can be configured to diffuse light emitted from any of the one or more LEDs 96, and, in some cases, to filter the emitted light into a range of or a particular frequency. The cap 70 can have an exterior surface comprising a cylindrical attachment portion 100 that is configured to couple or mate with the distal end of the tubular housing 50, and a dome-shaped portion 102 that may extend outward or project from the tubular housing. In one example, the cylindrical attachment portion 100 can be shaped and sized so that a snug fit is formed with the interior surface of the tubular housing 50. A bonding agent may be used to further secure the cylindrical attachment portion 100 to the tubular housing 50. The connection between the cap 70 and the housing 50 may be substantially waterproof to inhibit the ingress of liquid into the imaging assembly 18.

In some embodiments in accordance with one or more aspects of the invention, the cap 70 has an interior surface that defines a cavity extending inwardly from a proximal end of the cap. The cavity can provide or define a camera receiving portion 104 and an LED receiving portion 106. The camera receiving portion 104 can be correspondingly sized and shaped to snugly or tightly receive the sides 86B, 86C, 86D, 86E of the camera 84, and further can have a depth (indicated as “D” in FIG. 9) that is less than the height of the camera (indicated as “h” in FIG. 9) so that the camera extends out of the camera receiving portion 104 at the proximal end of the cap 70. This snug fit of the camera 84 in the camera receiving portion 104 inhibits movement of the camera relative to the cap 70 and facilitates proper alignment of the cap 70 with the camera 84. The position of the cap 70 relative to the camera 84 may be adjusted or configured to at least partially reduce any effects that undesirably affects the quality of the image generated by the imaging assembly 18. In the exemplarily embodiment, the protruding portion of the camera housing that extends outside of the camera receiving portion can facilitate assembly by enabling the use of a fixture for precise positioning of the camera and the cap. In other variants, the cap may utilize different configuration to interface with the housing or other components of the imaging assembly. For example, one or more variants embodiments may involve having circular cylindrical volumes enclosing any of the one or more of the light sources and the imaging devices.

Referring further to FIG. 9, the interior of the cap 70 can be further configured to reduce unwanted light emitting from the LED 96 from entering the camera 84 and being sensed or detected by the camera. To minimize or at least partially reduce any reflection of undesirable light into the camera 84, an interior camera-opposing surface 108 of the cap 70, opposing the upper surface 86F of the camera housing 86, can be oriented or constructed to be substantially parallel to the upper surface 86F of the camera housing. Moreover, an interior light-opposing surface 110 of the cap 70 opposing the light emitting surface 98 of the LED 96 can be disposed to be spaced longitudinally, i.e., distally, from the camera-opposing surface 108 of the cap. A relatively sharp angle, e.g., a right angle, may be implemented and defined by the camera-opposing surface 108 and an interior surface 112 of the cap 70 that connects the interior surface 110 to the interior surface 108. This configuration should reduce any undesirable internal reflection of light emitted by the LED 96 into the camera 84.

Referring further to FIG. 10, the dome-shaped portion 102 of the exterior surface of the cap 70 includes central distal portion 116 that can be generally flat, e.g., generally planar. Side edges extending from the distal portion 116 to the base, e.g., proximal end of the dome-shaped portion, are round and generally smooth. Moreover, the base of the cap 70 has a cross-sectional size and shape that can be approximately the same as the cross-sectional size and shape of the housing 50 so that the cap transitions smoothly to the housing. Overall, this general shape of cap 70 is referred to herein as a truncated-dome shape. The flat, central distal portion 116 should minimize or at least reduce distortion in the field of view. In the illustrated embodiment, the flat, central distal portion 116 has a generally circular circumference and an area that is the same size or larger than the field of view to further minimize distortion in the field of view. Moreover, the portion of the interior surface of the cap 70 that opposes the flat central portion 116 of the exterior surface (and the upper surface 86F of the camera 84) can also be flat and can be substantially in parallel with the flat central portion of the exterior surface, which should further minimize or at least reduce distortion in the field of view. The round edges of the cap 70 can facilitate insertion of the distal portion of the feeding tube assembly 12 into the subject and promotes comfort during intubation.

FIG. 11 shows an electrical block diagram directed to an exemplary electrical system 200 of the flex circuit assembly 60 in accordance with one or more embodiments of the invention. FIGS. 12 and 13 illustratively show circuit diagrams of the exemplary electrical system 200. The electrical system 200 can include an electrical conductor connector 202, such as an insulation displacement connector, for receiving the electrical conductors 24 from the outlet adaptor 20. According to the illustrated embodiment, the electrical conductors 24 include six signal lines. The six signal lines in the illustrated embodiment include two power supply lines (e.g., a power line, 5V, and a ground line, GND), two serial communication lines (e.g., a serial clock line, SCL, and a serial data line, SDA), and a differential pair (e.g., a low voltage differential signal positive line, LVDS_P, and a low voltage differential signal negative line, LVDS_N). The power supply lines (5V and GND) are electrically connected to the LED 96 for energizing the LED 96. In the illustrated circuit system 200, the power supply lines provide 5 Volt power to a white light LED (e.g., part number LW QH8G or LW VH8G available from OSRAM Opto Semiconductor GmbH, Germany). The power supply lines (5V and GND) are also electrically connected to a dual voltage regulator 204 (i.e., power supply) for providing power thereto. The dual voltage regulator 204 generates two different voltage lines from the power provided by the power supply lines. In the illustrated circuit system 200, the dual voltage regulator 204 (e.g., part number ISL9016IRUJCZ-T available from Intersil Corporation, Milpitas, Calif.) generates a 2.8 Volt power signal (e.g., analog supply voltage signal VAA) and a 1.8 Volt power signal (e.g., digital supply voltage signal VDD). The dual voltage regulator 204 is configured and electrically connected to supply voltage generated therefrom to an oscillator 206, a serial communication device 208, and the camera 84. In the exemplary electrical system 200, the camera 84 can be part number MTV9124M01, available from Aptina Imaging Corp., San Jose, Calif. However, other cameras or image sensors may be used without departing from the scope of the invention.

The oscillator 206, such as an 22 MHz oscillator, can be electrically connected to the camera 84 and configured to provide a timing signal (EXTCLK) thereto. The serial communication device 206, such as, an I2C bus repeater, available from Philips Semiconductor or NXP B.V, Germany, is electrically connected to the two serial communication lines (SDA, SCL) and to the camera 84 for allowing data, i.e., non-image data, to be communicated to and from the camera 84. For example, the serial communication lines (SDA, SCL) may be connected via the console connector 22 to an external computing device. The external computing device receives data representative of one or more camera settings, such as but not limited to resolution and frame rate. The camera settings can be communicated to the camera 84 via the serial communication lines (SDA, SCL) and the serial communication device 208. The camera 84 obtains images of the subject's anatomy in the field of view during and/or following intubation thereof and generates imaging signals such as a serialized digital video signal from the obtained images as a function of the camera settings communicated via the serial communication device 208. Operations performed by the camera 84 are synchronized as function of timing signal (EXTCLK) provided by the oscillator 206. The camera 84 outputs the signals, e.g., serialized digital video signal, to the differential pair lines (LVDS_N, LVDS_P) for transmission to the console connector 22 and to the console 23. The images obtained by the camera 84 may then be delivered, processed, and viewed via the console 23.

FIG. 14 illustrates the flex circuit 80 in an unfolded, or flat (e.g., planar), configuration. In the unfolded configuration, the camera mounting portion 82, the power mounting portion 90, the data mounting portion 92, and the light mounting portion 94 all lie generally in the same plane and form a single planar surface (e.g., mounting face). In one embodiment, all of the electrical components of the electrical system (e.g., electrical system 200) for the imaging assembly 18 are attached to a single, generally planar mounting surface 250 of the flex circuit 80 when the flex circuit is in the unfolded configuration. Accordingly, the electrical components may be attached to the flex circuit 80 while it is in the unfolded configuration to facilitate manufacturing.

Relative locations of the electrical components of the exemplary electrical system 200 described above are shown in FIG. 14. In particular, the electrical conductor connector 202 (e.g., insulation displacement connector) and the power supply 204 (e.g., dual voltage regulator) can be attached to the mounting surface 250 of the power mounting portion 90. A configuration, such as the illustrated configuration, in which the power supply 204 is typically located relatively close to the incoming electrical conductors 24, minimizes or reduces noise on the ground line (GND). The oscillator 206, e.g., timing generator, and the serial communication device 208, e.g., I²C bus repeater, can be attached to the mounting surface 250 of the data mounting portion 92. The camera 84 can be attached to the mounting surface 250 of the camera mounting portion 82. The exemplarily illustrated configuration locates the serial communication device 208 further from the electrical conductor connector 202 than the camera 84 because serial communication signals, e.g., serial data and serial clock signals, communicated between the serial communication device 208 and the electrical conductor connector 202 have a lower bandwidth than the video signal communicated from the camera 84 to the electrical conductor connector 202. An LED 96 is attached to the light mounting portion 94. The camera mounting portion 82 is shaped and configured so that the light mounting portion 94 can be disposed to be flush with a side 86C of the camera housing when the flex circuit assembly 60 is in the folded configuration described above.

In one embodiment, the flex circuit 80 of flex circuit assembly 60 is a two layer circuit. In particular, the flex circuit 80 includes a first substrate and a second substrate, each having top and bottom surfaces. The first and second substrates may be composed of a flexible polyimide film. Electrically conductive material, e.g., copper, selectively disposed on the top surface of the first substrate forms a first circuit pattern, e.g. plurality of selectively connected traces. FIG. 15 illustrates a first circuit pattern for the exemplary electrical system 200 in accordance with some aspects of the invention. Electrically conductive material selectively disposed on the top surface of the second substrate forms a second circuit pattern. The first and second substrates are arranged in parallel with one another (e.g., stacked) so that the top surface of the first substrate directly opposes the bottom surface of the second substrate. The first circuit pattern and the second circuit pattern are electrically connected together by using, for example, vias, and connected with the electrical components attached to the flex circuit to form a two layer circuit. The flex circuit 80 may be composed of other material and may be formed in other ways without departing from the scope of the present invention.

In one embodiment, the light mounting portion 94 of the flex circuit 80 is configured to function as a heat sink. The electrically conductive material on the top surface of the first substrate and the electrically conductive material on the top surface of the second substrate and can be connected together using, for example, vias, to conduct heat from the first substrate to the second substrate. The traces formed on the second substrate of the light mounting portion of the flex circuit can be wider relative to traces formed on other portions of the first and second substrates. For example, the wider traces may have a width of about 0.008 inches. This configuration minimizes or can reduce the likelihood of a temperature increase resulting from heat generated by the LED 96, and can allow a greater current to be provided to LED 96 to maximize or increase the illumination capability generated by the LED 96, while preventing or reducing the likelihood of any damage to the LED 96 and disturbances to the patient caused by undesirable or unacceptable high temperatures.

Referring to FIGS. 7, 8, and 14, in order to convert the flex circuit assembly 60 from the flat configuration to the folded configuration, the power mounting portion 90 and the data mounting portion 92 are folded toward each other at first fold lines 97 (FIGS. 7 and 8) to form the camera mounting surface 82 between the fold lines 97. The power mounting portion 90 and the data mounting portion 92 can be folded a second time at second fold lines 99 so that the two portions are generally parallel and in opposing relationship to one another. The light mounting portion 94 also can be folded inwardly toward the camera mounting portion 82.

Alignment of the power mounting portion 90 and the data mounting portion 92 during assembly can be facilitated because there would be no components disposed on the inner or back surface of the flex circuit, i.e., the components are mounted on the mounting surface. The alignment of the power mounting portion 90 and the data mounting portion 92 also can improve the alignment of the camera to a desired orientation. The stresses and forces associated with the foldlines 97 and 99 on either side of the camera mounting surface 82 balance each other out. As a result, the equivalent or counteracting stresses or forces induces positioning the camera 84 into a particular orientation such that the lens 88 is aligned with the cap 70 and the viewing field of view of the lens 88 is can be coincident with the axis of the tubular housing 50.

FIG. 16 is a block diagram of an exemplary flex circuit electrical system according to an alternative embodiment of the invention. As shown, the electrical conductors include four cables constituting four signal lines. The four signal lines in the illustrated embodiment include two power supply lines (e.g., a power line, 5V, and a ground line, GND) and a differential pair (e.g., a low voltage differential signal positive line, LVDS_P, and a low voltage differential signal negative line, LVDS_N). A microcontroller 210 cooperates with camera 84 to allow integration into feeding tube assembly 10. The camera 84 includes, for example, an I2C command/control interface and a serialized digital video output interface. The microcontroller 210 can send command and control signals directly to camera 84 rather than transmitting these signals over the length of the tube. Other operating parameters described herein, such as the exemplary embodiments associated with FIGS. 11-13, may be implemented in this variant.

In FIG. 17, the electrical conductors 24 include four cables constituting four signal lines in accordance with one or more further embodiments of the invention. The camera 84 can be customized to operate automatically and/or autonomously to a predefined operating protocol when powered up or energized. In this embodiment, camera 84 does not use or rely on external, incoming command/control signals. The operating parameters of the camera 84, such as, but not limited to, exposure, white balance, can be pre-programmed, pre-set, or permanently set to custom or tailored values for, for example, a particular or predefined application. In one embodiment, for example, the custom values would typically be stored in an associated memory structure. Camera 84 can include a sequencer (not shown), such as a microcontroller integrated in the camera module itself, which has a one time programmable memory (OTPM) (not shown) that can be programmed with the custom values. Alternatively, camera 84 can include hardware registers (not shown) that have the custom values stored therein, in which case the sequencer may be optionally operable. Other operating parameters described herein may be implemented in this embodiment.

FIG. 18 illustrates yet another embodiment of an exemplary flex circuit electrical system. As shown in FIG. 18, the electrical conductors 24 include two cables constituting two signal lines. The two signal lines in the illustrated embodiment include two power supply lines (e.g., a power line, 5V, and a ground line, GND) for supplying power from a console to the flex circuit 60. The console 23 can energize or provide power to the flex circuit 60 and can regulate voltage as needed to power a radio 212A as well as the camera 84 and other components of the flex circuit 60. The camera 84 can then send imaging signals, such as video data, via radio 212A wirelessly to a corresponding radio 212B located at the console. In an alternative embodiment, the console 23 and the camera 84 can communicate bi-directionally via radios 212A, 212B to exchange, for example, non-video data. Providing power to camera 84 in this manner can eliminate the need for a limited-capacity energy source, such as a battery, in the camera module itself.

Reducing the number of signal lines as shown in FIGS. 16-18, especially when combined with a flex circuit, may reduce cost and improve reliability and ease of assembly. And, fewer conductors reduce the likelihood of inadvertently switching lines and incorrectly connecting them during assembly.

Referring to FIGS. 2 and 4A, the exemplarily illustrated console connector 22 includes a connector housing 228 and a printed circuit board (PCB) 230, secured to the connector housing. The PCB 230 includes an edge connector 232 extending outward from the housing 228 so that an electrical component mounting portion of the PCB is disposed in the connector housing 228 and the edge connector is exposed and thus can be generally accessible for a connection thereto. In the illustrated embodiment, the connector housing 228 defines a tube-connection opening 234 in which the first and second tube segments 12 a, 12 b are secured, such as by an adhesive, to fluidly connect the first and second tube segments. The tube-connection opening 234 may partially define the feeding passage 14, or the feeding passage may be entirely defined by the tube segments 12 a, 12 b. In one non-limiting example, a one-piece tube 12, incorporating or in lieu of segments 12 a and 12 b, extends through the tube connection opening 234, such that the feeding passage is entirely defined by the tube and is not in fluid communication with any portion of the console connector 22. The tube 12 may be secured within the tube-connection opening 234, such as by adhesive. The console connector may be of other configurations and may be secured to the feeding tube assembly at other locations.

The electrical conductors 24 extend from the first tube segment 12 a into the connector housing 228 and are electrically connected to the PCB 230. An interface cable 242 (or other signal-transmitting component) can be removably connectable to the edge connector 232 to effect communication and data exchange between the console 23 and the imaging assembly 18. As explained in more detail below, an electronic memory component 243, such as electrically erasable programmable read-only memory (EEPROM), may be mounted on the PCB 230 to allow information (i.e., data) to be stored and/or written thereon and to be accessible by the console 23 (i.e., a microprocessor 254 of the console 23) or another external device. It is understood that the PCB 230 may have additional or different electrical components mounted thereon, or the PCB may be omitted such that the electrical conductors are operatively connected to the PCB 230.

In another embodiment, a console connector may be formed on or secured to an inlet adaptor. Referring to FIG. 4B, in one embodiment of the invention, a housing 228′ of a console connector 22′ is formed integrally with an inlet adaptor 16′. The console connector housing 228′ extends laterally outward from an outlet port 34′ of the inlet adaptor 16′. Like the previous embodiment, the current console connector 22′ optionally includes a PCB 230′ with an edge connector 232′ for use in communicatively connecting the imaging assembly with the console. An electronic memory component, such as an EEPROM (not shown) may be mounted on the PCB 230′, as disclosed above and explained in more detail below. The feeding tube assembly may include a different type of connection for connecting the imaging assembly 18 to the console 23.

Referring to FIG. 3, the illustrated interface cable 242 includes first and second interface connectors 244, 246 on opposite longitudinal ends of the cable. The first interface connector 244 is releasably mateable with and electrically connectable to the edge connector 232, and the second interface connector 246 is releasably mateable with and electrically connectable to the console 23. One or both of the interface connectors 244, 246 may be discriminating connectors (i.e., non-universal connectors) that will only mate and connect with respective connectors associated with the feeding tube assembly 10 and the console 23. Moreover, the edge connector 232 (or other connector) may be disposed within a socket having a shape that selectively and discriminatingly mates with a corresponding, e.g., complementarily configured, first interface connector 244. The socket and the first interface connector 244 may include engagement structures, such as ribs or other components that provide a friction-fit between the connector and the socket to inhibit inadvertent disconnection. The connection between the interface cable 242 and the console connector 22 may be of other configurations without departing from the scope of the present invention.

Referring still to FIG. 3, the interface cable 242 may include a control device, such as a button 248, to allow the user to record a still image, e.g., take a snapshot image, of real time video being displayed on the console 23. Actuating the button 248 or other control device sends a signal to the console 23 instructing the console to record image information, e.g., a still image along with associated temporal information. In one example, the control device 248 can be proximate or on the first interface connector 244; for example, the control device can be closer to the first interface connector than the first interface connector 246. In one or more exemplary embodiments of the invention, the control device can be provided on the first interface connector or within 12 inches of the first interface connector. The console 23 may also include a snapshot control function, e.g., an icon, button, or other actuation device that allows the user to take and record a snapshot image using the console, that can be optionally stored in a memory structure, and which may include ancillary information such as the date and time. In some situations or embodiments it is envisioned that during insertion of the feeding tube assembly 10 in the patient, the console 23 may be located at a distance that is not within reach of the user, such as a medical practitioner. Thus, although the images, e.g., video, may be viewable on the console 23, the user may not be able to reach the console to perform additional operations or functions on the console during insertion of the feeding tube assembly 10. Accordingly, by providing a control device 248 on the interface cable 242, and more specifically, by providing a control device that is adjacent the first interface connector 244, the user can take and record a snapshot image without having to reach for the console 23. The interface cable 242 may be of other configurations without departing from the scope of the present invention.

As shown in FIG. 3, the illustrated console 23 can include a console housing 250, a console display 252, such as an LCD or other electronic display, secured to the housing, and a microprocessor 254 disposed in the housing. In the illustrated embodiment, the microprocessor 254 communicates with the imaging assembly 18 through the interface cable 242 and the electrical conductors 24. The microprocessor 254 can be configured to receive the imaging signal or video signal transmitted by the imaging assembly 18 and display real-time images associated with the imaging signal on the display. As disclosed in more detail below, the microprocessor 254 can be optionally configured to display a graphical user interface on the console display 252, or a different display. The console 23 can include one or more user input devices to allow the user or operator to communicate with the microprocessor 254 to perform various operations using the console 23. The display 252 may be a touchscreen, such as a touchscreen LCD or other types of displays, which also functions as a user input device. In one embodiment, the touchscreen allows the image to be enlarged or reduced by touching the screen with two fingers and either moving apart to enlarge or bringing together to reduce the image size. Other user input devices, in addition to or in lieu of the touchscreen display 242, such as a mouse, a keyboard, a joystick, or other user input devices, may also be provided. Some other devices may include, without limitation, the ability to accept and act on voice commands or upon gestures by the clinician. These latter input devices have the advantage of not requiring that one be able to touch the console. Other ancillary components can be utilized in the console 23, including, but not limited to power supply subsystems and serial buses.

Referring to FIG. 4A, as disclosed above the console connector 22 on the feeding tube assembly 10 may include an electronic memory component 243, such as an EEPROM, for storing and/or writing data thereon that is accessible by the console 23 or other internal or external devices associated with the feeding tube assembly, such as the enteral feeding pump. One or more of the following types of information may be provided on or written to the electronic memory component in one or more embodiments of the present invention.

In one non-limiting example, data relating to the feeding tube assembly 10 may be written, stored, or otherwise incorporated into the electronic memory component 243. For example, data indicating the lot code and/or the item code, e.g., serial number, may be written to the electronic memory component 243, and be retrievable by the console 23 as a predefined identifier. Moreover, a proprietary verification code may be included in the electronic memory component 243 to provide information that can facilitate verification to the console 23 that the feeding tube assembly 10 is a valid feeding tube to be used with the console. The console 23 may be configured, by, for example, executing instructions, to verify that the feeding tube assembly is an acceptable, proper, unexpired, or compatible feeding tube assembly before allowing operation or additional operation. Without proper validation, for example, the console 23 may inhibit images from displaying on the console if the feeding tube assembly 10 does not have a valid information, such as an acceptable code or an acceptable predefined identifier. Also, data indicating whether the feeding tube assembly 10 is sterilized may be written to the electronic memory component 243. Other information relating to the feeding tube assembly 10 may also be written to or otherwise incorporated in the electronic memory component 243. The electronic memory component may thus serve as a validation assembly or key that would provide one or more predefined identifying information, e.g., a predefined identifier, that can be utilized by the console before or during operation thereof.

In another non-limiting example, the data indicating time (i.e., time stamps) relating to the feeding tube assembly 10 may be written to the electronic memory component 243. For example, the date of manufacture of the feeding tube assembly 10 may be written to electronic memory component 243. When the feeding tube assembly 10 is connected to the console 23, such as by the interface cable 242, the console may read the data indicating the date of manufacture. In one non-limiting example, the console 23 may use the date of manufacture to determine if the feeding tube assembly 10 has exceeded its storage life. If the feeding tube assembly 10 has exceeded its predetermined storage life, the console 23 may be configured or execute programmed instructions that perform at least one of initiate an alarm, communicate a message indicating that the storage life is exceeded, and prevent viewing of images from the imaging assembly 18. In another example, upon connection of the feeding tube assembly 10 with the console 23, the console may be programmed to write a start date of service or date of first use on the electronic memory component 243. This start date can be used as a reference to determine when the predefined usage life of the feeding tube assembly 10 has been exceeded or is about to expire. For example, after writing the start date to the electronic memory component 243, the console 23 may be configured to determine the usage duration or use life of the feeding tube assembly, and compare the elapsed usage duration with an expiration date (and time) to determine the remaining usage life or whether the service life, usage time, or both, of the feeding tube assembly will expire or has expired. Other variants may involve periodically, continually, or continuously determining whether the current date or usage date exceeds the expiration date. If the console 23 determines that the usage life of the feeding tube assembly 10 has expired, then the console may be programmed to at least one of initiate an alarm, communicate a message indicating that the usage life is expired, make a record on any recorded images, and prevent viewing of images from the imaging assembly 18. The cumulative use time may be determined by writing time stamps to the electronic memory component 243 to determine the hours of actual use.

The console 23 may be configured to write other information to the electronic memory component 243. For example, the console 23 may be programmed to write a serial number (or other identifier) associated with the console so that other consoles and other devices, such as enteral feeding pumps, can read the electronic memory component 243 and determine which console was used with the selected feeding tube assembly 10. In another non-limiting example, the console can be configured to write to the electronic memory component 243 patient specific information including, for example, the subject's (e.g., the patient's) name, the subject's identification code, and other information relating to the patient, including but not limited to, the type of enteral product to be fed to the patient as well as the patient's feeding schedule, feeding duration, associated feeding settings, or other historical information. The patient information may be written to the electronic memory component 243 before the feeding tube assembly 10 is connected to the console 23, and the console may be programmed to read the patient information. Alternatively, the user may use the console 23 to write the patient's information to the electronic memory component 243. The patient's information may be encrypted to ensure patient confidentiality.

In yet another non-limiting example, a placement-confirmation time stamp or some other confirmation identifier may be written to the electronic memory component 243 to indicate that the proper placement of the feeding tube assembly 10 in the patient was confirmed. The console 23 may be configured to write the time stamp to the electronic memory component 243 when the user indicates to the console that the feeding tube assembly is properly located. For example, the user may press a button or perform some other operation to confirm proper placement. In addition to a time stamp or other confirmation identifier, a username or other user identification can be written to the electronic memory component 243.

FIGS. 19-31 illustrate one or more features relating to an exemplary graphical user interface of the console. One or more of the features described herein may be incorporated into various embodiments of the invention. FIG. 19 is a flow chart illustrating the operations of the graphical user interface when the console 23 is powered on for the very first time, or when the console is activated after a predetermined time period of non-use by a user. The predetermined period of non-use can be one month, six months, or even one year. Other triggering conditions that may affect a first time start may involve a loss of power.

As illustrated, a user interface screen prompts a user to indicate whether the user is the very first user of the console 23 (hereinafter “initial user”), or whether the user has already been associated with the console. If the user is the initial user, the console 23 grants the initial user administrator status along with associated privileges for accessing all or predetermined features of the console. Accordingly, at 302, the initial user is prompted to select a language (labeled “Language”) that will be displayed on the user interface screens to communicate with users. At 304, the initial user is prompted to enter the current date and time, and optionally to specify a format for displaying the time (labeled “Date/Time”). At 306, the initial user is optionally prompted to enter time tracking options for display by the user interface (labeled “Time Display”). The initial user can select one of the following options: the current time of day is tracked and displayed by the console 23; the elapsed amount time for the current procedure being conducted by the feeding tube assembly 10 (e.g., initiated when patient data is entered) is tracked and displayed by the console; both, the current time of day and the elapsed amount of time for the current procedure being conducted are tracked and displayed by the console. At 308, the initial user is optionally prompted to set up an administrator account by entering a username and a password.

If the user indicates that the user is not the very first user of the console 23, the console, at 310, presents to the user a log-in user interface screen. The user enters a username and password. If the user enters a valid username and password associated therewith, the user is logged in. If the console 23 determines that the username and password are not valid, the console presents the user with a log-in retry (i.e., message and another opportunity to log in). In one embodiment, after a predefined number of log-in attempts, the console 23 may be reset; all patient data, user data, and device data may be deleted, locked or becomes otherwise inaccessible. If the user is successfully logged in, at 312, the user is presented with a main selection user interface screen. The main selection user interface screen can present the user with one or more of the following navigational options: utility functions, procedure screen, file functions, and logout. The navigational options may be presented via text and/or graphical icons. In addition, a portion of the main selection user interface screen (labeled “Preview Video” or graphically represented as a movie reel icon, for example) is dedicated to providing the user with video data if video data is being received from the imaging assembly 18 when the main selection user interface screen is being accessed. As described below, this generally occurs when the user selects the main selection user interface screen after initiating a procedure.

In one embodiment, the console 23 is configured to recognize a plurality of classes (i.e., statuses) of users, and to limit operations that may be performed by the console as a function of a class associated with each user. For example, the console 23 may be configured to recognize four classes of users: operators, administrators, approvers, and maintainers. The console 23 can be configured to authorize the operator class of users to view video data that is received from the imaging assembly 18. The console 23 can be configured to authorize the administrator class of users to create or establish user accounts or other operator accounts, along with respectively associated data storage substructures, and to view video data that is received from the imaging assembly 18. The console 23 is configured to authorize the approver class of users to view video data or imaging data that is received from the imaging assembly 18 and to annotate approval data onto the video data or imaging data received from the imaging assembly. The console 23 can be configured to authorize the maintainer class of users to perform maintenance functions to the console such as software updates. However, the console 23 only authorizes the maintainer class of users to operate the console if the console is not storing any patient data, e.g., patient data must be deleted from console before a maintainer user is authorized to operate the console.

If the user selects the utility functions from the main selection user interface screen, a utility functions user interface screen can be presented to the user. The options presented to the user on the utility functions user interface screen are typically based on the class (i.e., status) associated with the user. If the user is an operator or an approver, the user can be presented with a utility functions user interface screen. The console can then provide the user with the “Language” option and the “Preview Video” feature discussed above. The utility functions user interface screen also can provide the user with a “User Manager” option which allows the user to navigate to a user manager navigation user interface screen that allows the user to change his/her password. If the user is an administrator, a utility functions user interface screen presented to the user has the “Language,” “Date/Time,” “Time Display,” and “Preview Video” options discussed above. A “User Manager” option can also be provided, which allows the user to navigate to a user manager user interface screen. A user manager user interface for the administrator allows the administrator to add a user via the user interfaces. The utility functions user interface screen presented to the administrator also can also have an option, labeled “Reset/Erase Console,” for resetting (deleting patient data, user data, and device data) or erasing the console (deleting patient data and device data) and for performing a software update, labeled “SW Update”. In addition to the options presented to an administrator user, the utility functions user interface screen presented to a maintainer user additionally provides the maintainer user with the option to perform maintainer functions (labeled “Maintainer Functions”). For example, “Maintainer Functions” may include software debugging functions.

Referring again to the main selection user interface screen if the user selects the “Procedure Screen” option, a patient information user interface screen is displayed to the user via the console 23. The patient information user interface screen prompts the user to enter a name and identification for the patient for which the procedure is being performed. If the user enters the name and identification of the patient, the procedure main user interface screen is displayed to the user and the console 23 begins receiving video data from the imaging assembly 18 of the feeding tube assembly 10 so long as the feeding tube assembly 10 is correctly connected to the console. If the user does not enter the name and identification of the patient, e.g., leaves the Patient Name and Patient ID fields blank, the user is presented with the blank patient information user interface screen. The blank patient information user interface screen allows the user to select to proceed without the entering the patient information or to enter the patient information. If the user selects to enter the patient information, the user can be re-directed to the patient information user interface screen. If the user selects to proceed without entering the patient information, the procedure main user interface screen is displayed to the user and the console 23 begins receiving video data from the imaging assembly 18 of the feeding tube assembly so long as the feeding tube assembly 10 is correctly connected to the console. If the feeding tube assembly 10 is not connected or is incorrectly connected to the console, the user is presented with an error message.

In one embodiment, the patient information may be manually entered by the user. In another embodiment, the console 23 may include a bar code scanner (not shown) for scanning the patient's bar code wrist band to obtain the patient information. In yet another embodiment, the patient information can be provided on the electronic memory component 243. After communicatively connecting the feeding tube assembly 10 to the console 23, the console may read and record the patient information from the electronic memory component 243. This embodiment may be combined with the bar code scanner embodiment and/or the manual-input embodiment to provide a cross-check for the patient to ensure that the correct medical procedure (e.g., enteral feeding) is being provided to the correct patient.

As illustrated in FIGS. 20 and 21, alternative procedure main user interface screens can display the video data or the rendered or processed imaging data being received by the console 23 from the imaging assembly 18. The procedure main user interface screen also can display any of the current time (if selected by the user) at 350, the patient name and identification number (if entered by the user) at 352 and 354, respectively, and the time elapsed for the current procedure (if selected by the user) at 356. The time elapsed for the current procedure begins when the user enters the patient name and identification or selects to proceed without entering the patient name and identification. The procedure main user interface screen also includes an option (e.g., icon or button with text) for taking a snapshot at 358. The snapshot option 358 allows a user to select to store the current frame of the video data or the rendered imaging data collected by the console from the imaging assembly 18. Identifying information about the snapshot may be automatically provided and/or entered by the user on the console for later identification of the snapshot. As disclosed above, the interface cable 242 may include a control device 248, which may be provided in addition to or in lieu of the snapshot option 358 on the console 23. At 360, the procedure main user interface screen provides the user with the file functions option (labeled “File Functions” or illustrated as a folder icon) which allows the user to access files stored by the console. The “File Functions” option may also be accessed directly from the main selection user interface screen. Upon selecting the “File Functions” options from either the procedure main user interface screen of FIGS. 19A and 19B, for example, or the main selection user interface screen, the user is directed to the file functions user interface screen.

The file functions user interface screen presents a user with a list of directories stored on the console, and also includes the “Preview Video” feature discussed above. Each directory represents the video data or the rendered imaging data that is stored in connection with one particular feeding tube assembly 10. In one embodiment, the console 23 can read a serial number or other unique identifier from the console connector 22. The serial number or other identifier may be specific to the feeding tube assembly 10 such that it distinguishes it from all other feeding tube assemblies. In the illustrated embodiment, the console connector 22 includes the electronic memory component 243 that stores the identifier for the feeding tube assembly 10. All of the data that is received from the feeding tube assembly 10 having a particular serial number or other identifier can be stored under a single directory in the console 23. Data that is received from a feeding tube assembly 10 having a different serial number or other identifier can be stored under a different directory.

A user may select a directory for viewing and/or editing from the file functions user interface screen. When the directory is selected from the file functions user interface screen, the user is directed to the file functions directory selected user interface screen (alternative embodiments illustrated in FIGS. 22 and 23). This user interface presents the list of files (e.g., image files) associated with the selected directory. The image files represent the images selected by the user via the snapshot option. The user is able to select at least one file from the image directory and export the file via the “Export” option 380, rename the file via the “Rename” option 382, delete the file via the “Delete” option 384, and annotate or view the file via the “Annotate/View” option 386.

If the user selects the “Export” option 380 from the file functions user interface screen, the raw/JPEG user interface screen (alternative embodiments illustrated in FIGS. 24 and 25) is displayed. This user interface presents the list of files associated with the previously selected directory and allows the user to select one or more files. The user interface allows the user to specify a particular console universal serial bus (USB) port at 390 through which the selected files will be exported. A suitable number of busses may be provided. In one embodiment two, stacked busses are provided. In another embodiment, the console 23 may additionally or alternatively be configured to export the selected files wirelessly to a receiving device and/or to export the selected files to the receiving device via an Ethernet connection. At 392, the user is also presented at 392 with the option to delete the selected files from the console once the selected files have been exported. At 394 and 396, respectively, the user is prompted to select whether to export the file as an uncompressed file (e.g., raw file) or to export the file as a compressed file (e.g., JPEG file).

If the user selects the “Rename” option 382 from the file functions user interface screen, a rename user interface screen is presented to the user to allow the user to rename the file. In one embodiment the default format of the file is DATE_SUD-SN PT-NAME_PTID_TIME_SEQ#.img, wherein

-   -   DATE=the current date (e.g., yyymmdd) set to the console via the         “Date/Time” feature     -   SUD-SN=single use device serial number (e.g., the identifier         retrieved by the console 23 from the console connector 22)     -   PT-NAME=patient name as entered by the user via the patient         information user interface screen     -   PT-ID=patient identifier as entered by the user via the patient         information user interface screen     -   TIME=the current time (e.g., hhmmss) set to the console via the         “Date/Time” feature     -   SEQ#=the image number as received from the imaging assembly,         wherein the first image sent from the imaging assembly has an         image number of 1 and the image number for each image received         thereafter is incremented by one.

In one embodiment, the “Rename” option 382 allows the user to change only the SEQ# portion of the file name.

If the user selects the “Delete” option 384 from the file functions user interface screen, the delete user interface screen is presented to the user to allow the user to delete files. The delete user interface screen can provide the user with a list of the files included in the previously selected directory. The user can select one more files from the directory and then select the delete option (e.g., delete button/icon). When the user selects the delete option from the delete user interface screen, the user is prompted via the delete confirmation user interface screen, to confirm that the selected files should be deleted from the console. Once the user confirms that the selected files should be deleted, the selected filed are deleted from the console.

If the user selects the “Annotate/View” option 386 from the file functions user interface screen, a view user interface screen as shown in the alternative embodiments of FIGS. 26 and 27 is displayed. The view user interface screen can display the image stored in the selected file. The view user interface screen also can provide the user with an “Annotate” option at 400 and a “Compare to Video” option at 402. If the user selects the “Compare to Video” option at 402, the console 23 presents a compare user interface screen to the user (alternative embodiments illustrated in FIGS. 28 and 29). A first portion 404 of the compare user interface screen displays the image stored in the selected file. A second portion 406 of the compare user interface screen can display video data or rendered imaging data currently being received by the console from the imaging assembly 18. The images on both the first and second portions 404, 406 can in one embodiment be zoomed or panned. By comparing a previously captured image illustrating prior tube placement within a patient to current video data illustrating current tube placement within the patient, a user can determine whether the tube has migrated within the patient. Additionally or alternatively, a user can compare an image of a previously placed tube to current information representative of a current tube placement to facilitate assessment as to whether the tube currently appears to be placed appropriately. It should be noted that the first portion 404 and the second portion 406 of the compare user interface screen are illustrated as being horizontally aligned; however, the first and second portions, 404 and 406 maybe alternatively arranged with respect to one another (e.g., vertically aligned), and may be modified by the user without departing from the scope of the invention.

The compare user interface screen provides the user with an “Annotate” option at 408 and a “Procedure Screen” option at 410. If the user selects the “Procedure Screen” option 410, the console redirects the user to the patient information user interface screen described above. If the user selects the “Annotate” option 408 from the compare user interface screen (FIGS. 28 and 29), or the “Annotate” option 400 from the view user interface screen (FIGS. 26 and 27), the console presents the user with an annotate user interface screen illustrated in the alternative embodiments of FIGS. 30 and 31. The annotate user interface screen presents the user with a “Text” option at 420, and “Line” option at 422, and “Approve” option at 424, an “Undo” option at 426, and an “Undo All” option at 428.

If the user selects the “Text” option 422, the annotate user interface screen allows the user to indicate (e.g., touch, click, etc) the portion of the image being displayed on the annotate user interface screen where the user would like to place the center of the text. After receiving the user input indicating the location of the text, the annotate user interface screen displays additional options to the user. In particular, the annotate user interface screen provides the user with the option to select text naming an anatomical structure from a text list of anatomical structures. The annotate user interface also provides the user with the option to add free-text to the image. If the user selects text naming an anatomical structure from the text list, the selected text appears on the screen centered over the user-selected text location. If the user selects to add free-text to the image, the annotate user interface screen adds a keyboard to the annotate user interface screen and allows the user to enter text accordingly. If the keyboard on the annotate user interface screen covers the user-selected text location, the text entered by the user is moved upward until the user finishes entering the text. Once the text entry has been completed, the entered text can be displayed on the screen centered over the user-selected text location.

If the user selects the “Line” option 422 the annotate user interface screen allows the user to indicate (e.g., touch, click, etc) the portion of the image being displayed on the annotate user interface screen where the user would like to place a first end of a line segment. The user may then indicate, e.g., via a drag and drop operation, where the second end of the line segment should be located on the annotate user interface screen. If the “Undo” option 426 is selected, the last unsaved annotated item, e.g., text, line segment, is removed from the image. This operation can be repeated until there are no unsaved annotated items remaining in the image. If the “Undo All” option 428 option is selected, all unsaved annotated items are removed from the image.

If the user selects the “Approve” option 424, the user can be re-directed to the approver user interface screen. The approver user interface screen prompts a user to enter his/her username and password. Once the username and password are entered, the console attempts to authenticate the user as being associated with approver status. If the user is authenticated, a message, such as “Approved by USERNAME on DATE at TIME” is added to the image (e.g., upper left of image beneath the patient identification information, wherein

-   -   USERNAME=the username of the current user as entered in the         approver user interface screen     -   DATE=the current date (e.g., yyymmdd) set to the console via the         “Date/Time” feature     -   TIME=the current time (e.g., hhmmss) set to the console via the         “Date/Time” feature

Once an approver user has indicated that he/she approves the placement of the tube, the patient is allowed to be provided with nutrients via the feeding tube assembly 10. For example, the console may be configured to provide a signal that allows operation of feeding pump.

The order of execution or performance of the operations in embodiments of the invention illustrated and described herein is not essential, unless otherwise specified. That is, the operations may be performed in any order, unless otherwise specified, and embodiments of the invention may include additional or fewer operations than those disclosed herein. For example, it is contemplated that executing or performing a particular operation before, contemporaneously with, or after another operation is within the scope of aspects of the invention.

Embodiments of the invention may be implemented with computer-executable instructions. The computer-executable instructions may be organized into one or more computer-executable components or modules. Aspects of the invention may be implemented with any number and organization of such components or modules. For example, aspects of the invention are not limited to the specific computer-executable instructions or the specific components or modules illustrated in the figures and described herein. Other embodiments of the invention may include different computer-executable instructions or components having more or less functionality than illustrated and described herein.

Referring to FIGS. 32A-42, another embodiment of the imaging feeding tube assembly is generally indicated at 510. This embodiment is similar to the various embodiments disclosed above, and like components are indicated by corresponding reference numerals plus 500. Referring to FIGS. 32A and 32B, the imaging feeding tube assembly 510 includes a feeding tube 512, a inlet adaptor, generally indicated at 516, adjacent a second longitudinal end (i.e., a proximal end) of the tube, an imaging assembly, generally indicated at 518, adjacent a first longitudinal end (i.e., a distal end) of the tube, and a console connector, generally indicated at 522, secured to the tube intermediate the inlet adaptor 516 and the imaging assembly 518. The imaging feeding tube assembly 510 may be used with the console 23, or a different console or display, for displaying image(s) generated by the imaging assembly 518, as disclosed above. The inlet adaptor 516 is analogous to the inlet adaptor 16, and therefore, reference is made to the prior inlet adaptor for an explanation of various features of the inlet adaptor 516. Unless otherwise specified below, disclosures relating to the components of the previous feeding tube assembly embodiment 510, set forth above herein, also apply to the components of the current feeding tube assembly embodiment 512.

The tube 512 can be a one-piece tube. Referring to FIG. 33, electrical conductors 524 (broadly, a signal transmission component) extend longitudinally along substantially the entire length of the tube 512 from the imaging assembly 518 to the console connector 522. In the illustrated embodiment, there are six electrical cables 524 for powering the imaging assembly 518 and transmitting data between the console (e.g., console 23) and the imaging assembly, although there may be more or less cables without departing from the scope of the present invention. In the illustrated embodiment the cables 524 are disposed in three separate and distinct conductor passages 526. The cables 524 are provided in pairs, with each pair being disposed within the same conductor passage 526 in the tube wall. In one example, the cables 524 and the tube 512 may be co-extruded so that the cables are embedded in the tube wall. After co-extrusion, the cables 524 may be laser ablated to remove the respective jackets and/or mechanically stripped to expose the wires so that the cables can be electrically connected to the imaging assembly 518 and the console connector 522.

Referring to FIGS. 34-37, the imaging assembly 518 can include an elongate housing 550; a flex circuit assembly, generally indicated at 560 (FIG. 35), including a camera 584 and a light source 596 mounted thereon and received in the housing; and a cap 570 attached to the camera at a first longitudinal end, e.g., distal end, of the imaging assembly. In this embodiment, a flex circuit 580 of the flex circuit assembly 560 can be a rigid-flex circuit including one or more space apart rigid structures 561 mounted on the flex circuit which inhibit bending. The electrical components, such as those described above with respect to the previous embodiment, are mounted on the rigid structures 561. The rigid-flex circuit 560 is capable of bending at bending locations 581 between the rigid structures 561 such that the rigid-flex circuit is capable of selectively deforming solely at the bending locations 581 along the length of the folded rigid-flex circuit. As with the imaging assembly 18 disclosed above and as shown in FIGS. 34 and 35, the present imaging assembly 518 is bendable along its longitudinal axis LA2 in opposite first and second bending directions A1, A2 (i.e., within a bending plane) that is transverse to the longitudinal axis of the flex circuit assembly 560, and is generally unbendable or rigid in opposite third and fourth transverse directions A3, A4 (i.e., within a rigid plane) that are generally transverse to the both the first and second bending directions and the longitudinal axis of the flex circuit assembly. The catheter 510 may include a marking (not shown), similar to the marking 62 set forth above. The light source 596 and the camera 584 are mounted on the same distal camera mounting portion 582 of the rigid-flex circuit 560, which extends generally transverse to the longitudinal axis of the imaging assembly 518. In the illustrated embodiment, the camera mounting portion 582 can have one of the rigid structures 561 mounted thereon, to which the camera 584 and the light source 596 can be secured.

Electrical components for operating the imaging assembly 518 may be similar or the same as the electrical components disclosed above for operating the previous embodiment of the imaging assembly 18. In addition to those electrical components, the rigid-flex circuit 560 includes decoupling capacitors, generally indicated at 598, for providing a stable supply voltage with low noise to the camera 84. In the illustrated embodiment, the decoupling capacitors 598 are embedded in the camera mounting portion 582 of the rigid-flex circuit 560 between layers thereof. In this way, the decoupling capacitors 598 are immediately adjacent the camera 584.

Referring to FIGS. 40 and 42, the cap 570 may be similar to the cap 70 except that the cavity in the cap 570 is typically sized and shaped for receiving the camera 584 only, without the camera and the LED 596 as in the previous embodiment. In addition, referring to FIG. 40, the cap 570 includes a plurality of radial locking ribs 589 received in corresponding radial locking grooves 600 formed on the interior surface of the housing 550. The engagement between the locking ribs 589 and the locking grooves 600 inhibit longitudinal movement between the housing 550 and the cap 570. The cap 570 may be of other configurations without departing from the scope of the present invention.

In one non-limiting example (FIG. 40), the housing 550 may be molded and include longitudinally spaced apart reinforcing structures 591 (i.e., wall portions of housing 550 with increased thicknesses), and bending locations 593 (with wall thickness of housing 550 less that at structures 591) disposed between the reinforcing structures. The reinforcing structures 591 are typically disposed adjacent the electronic components and the rigid structures on the rigid-flex circuit 580, while the bending locations 593 are typically disposed adjacent the bending locations on the rigid-flex circuit. Through this configuration, the cap 550 further promotes bending of the imaging assembly 518 at selected locations along its length and inhibits bending at longitudinal locations where the electronic components are located. The difference in wall thickness of housing 550 with respect to structures 591 and locations 593 can be less than about 25%, less than about 10%, or less than about 5%.

In another non-limiting example (FIG. 41), the housing 550 may be molded over the cap 570, the rigid-flex circuit assembly 560, and the imaging assembly connector 520 to form an integral imaging assembly 518. For example, the cap 570, the rigid-flex circuit assembly 560, and the imaging assembly connector 520 may be placed in a fixture of an overmolding process, and then the housing 550 may be molded over the components. The material for overmolding may comprise urethane or other material. In yet another embodiment, the housing 550 may be pre-formed and the cap 570 and the imaging assembly connector 520 may be secured to the respective ends of the housing, such as by solvent bonding or in other suitable ways.

Referring to FIGS. 32A, 32B, 38 and 39, as with the previous feeding tube assembly 10, the current feeding tube assembly 510 includes an imaging assembly connector, generally indicated at 520. Like the previous embodiment of the imaging assembly connector 20, the current imaging assembly connector 520 defines a feeding passage outlet 540 that is in fluid communication with the feeding passage 514 of the tube 512. In the illustrated embodiment, the first longitudinal end of the tube 512 is received and secured in the feeding passage outlet 540 of the imaging assembly connector 520 to provide fluid communication therebetween. The outlet 540 is closed adjacent to prevent liquid nutrients from entering the imaging assembly 518. Thus, the imaging assembly 518 is not in fluid communication with the feeding passage 514. Instead, the feeding solution is dispensed laterally from the outlet 540 and to the patient (only one such lateral opening is shown in FIGS. 32 and 38).

Referring to FIGS. 38 and 39, a first longitudinal end (e.g., a distal end) of the imaging assembly connector 520 defines an alignment slot 521 for receiving a proximal end of the rigid-flex circuit assembly 560. The alignment slot 521 facilitates proper positioning of the rigid-flex circuit assembly 560 relative to the imaging assembly connector 520. The imaging assembly connector 520 may be of other configurations without departing from the scope of the present invention.

Referring to FIG. 42, the console connector 522 can be secured to the feeding tube 512 and can extend laterally outward therefrom. The present illustrated console connector 522 includes a housing 728, and a PCB 730, an inlet adaptor connector 800, and a feeding tube connector 802 secured to the housing. A connector, such as a USB port connector 532, may be mounted on the PCB 730 for communicatively connecting an interface cable to the PCB 730. In another embodiment, the PCB 730 may include an edge connector, as disclosed above with respect to the previous embodiment. An electronic memory component 743 may be mounted on the PCB 730. The housing 728 can define a socket 736 having a size and shape for mateably receiving an interface connector (not shown) having a corresponding size and shape. A connector cap 737 can be tethered to the housing 728 for selectively closing the socket 736 when it is not in use.

The housing 728 may be molded over the inlet adaptor connector 800 and the feeding tube connector 802 to secure the connectors to the housing. The proximal end of the feeding tube 12 is secured within a connection passage 804 in the feeding tube connector 802. The inlet adaptor connector 800 connects the inlet adaptor 516 to the console connector 522 and defines a passage 806 that fluidly connects the inlet adaptor 516 to the feeding tube 512. In another embodiment (not shown), the one-piece feeding tube 512 may pass through an opening in the console connector 522 and connect directly to the inlet adaptor 516. The housing 728 may be secured to the feeding tube 512 using adhesive or in other ways. The housing 728 may be secured to the inlet adaptor 516, more specifically, to the distal end of the inlet adaptor so that the housing abuts the inlet adaptor. The console connector 522 may have other configurations without departing from the scope of the present invention.

Referring to FIG. 43, another embodiment of an interface cable for connecting the feeding tube assembly 10, 510 to the console 23 is indicated at 742. The interface cable 742 is similar to the interface cable 242 of the previous embodiment. Like the previous interface able embodiment 242, the present interface cable 742 can include first and second interface connectors 744, 746 on opposite ends of the cable. The illustrated first interface connector 744 is sized and shaped to mate, e.g., to be selectively inserted into, the socket 736 of the console connector 522 and to make connection with the USB port connector 532, or an edge connector or another connector associated with the console connector. The first interface connector 744 includes annular ribs or beads 770 that engage an interior surface of the socket 736 to form a substantially liquid-tight seal therewith to prevent the ingress of fluid into the socket. The second interface connector 746 is sized and shaped to mate, e.g., to be selectively inserted into, with a corresponding socket of the console 23 and to make connection with the console. The first and second interface connectors 744, 746 and the corresponding sockets 736 can be configured so that the first interface connector 744 is not mateable with the socket on the console 23 and the second interface connector 746 is not mateable with the socket 736 of the console connector 522. The interface cable 742 may be of other configurations without departing from the scope of the present invention.

In the illustrated embodiment, first interface connector 744 can include an imaging signal buffer component 750 (e.g., an I²C buffer component) which drives imaging signals (e.g., I²C signals) between the imaging assembly 18, 518 and the console. By locating the imaging signal buffer component 750 in the first interface connector 744, the capacitance is split approximately equally between the conductors 24, 524 (e.g., wires in the cables) in the feeding tube assembly 10, 510 and the conductors (e.g., wires) in the interface cable 742. This configuration minimizes or reduces capacitance in any one segment of the system and maximizes or improves the image signal integrity. Moreover, the first interface connector 744 and the imaging signal buffer component 750 will be desirably adjacent the feeding tube assembly 10, 510 because the console connector 22, 522 is mateable only with the first interface connector, and not the second interface connector 746. The interface cable 742 may not include an imaging signal buffer component 750 and may be of other configurations without departing from the scope of the present invention.

Referring to FIGS. 48 and 49, a feeding tube assembly packaging, including the feeding tube assembly 510, is generally indicated at reference numeral 900. It is understood that the feeding tube assembly packaging 510 may include a different embodiment of the feeding tube assembly, including but not limited to the feeding tube assembly 10. The feeding tube assembly 510 may be packaged in a sterile package, generally indicated at 902, of the packaging 900. The package 902 may include a container 904 in which the feeding tube assembly 510 is received, and a lid 906 removably secured to the container for enclosing the feeding tube assembly. The container 904 defines a central, generally circular cavity 910 in which the feeding tube 510, which is wound generally in a coil, is received. In addition, the container 904 defines an imaging assembly cavity 912 in which the imaging assembly 518 is received, and an adaptor cavity 914 in which the adaptor 516 is received. The imaging assembly cavity 912 has an elongate, curvilinear shape. Curvilinear side walls 918 of the imaging assembly cavity 912 engage the imaging assembly 518 to bend the imaging assembly into a preferred curvilinear shape. The imaging assembly 518 conforms generally to the shape of the imaging assembly cavity 912. As set forth above, this preferred curvilinear shape facilitates insertion of the imaging assembly 518 through the nasopharynx. When feeding tube assembly 510 is removed from the packaging 902, the imaging assembly 518 may fully or partially retain this preferred curvilinear shape. Thus, in some cases, at least a portion of the feeding tube assembly, such as the imaging assembly thereof, may assume a set, e.g., an arcuate or curvilinear shape, which can facilitate nasogastric insertion thereof. In the embodiment where the feeling tube assembly may include the marking 62, the marking may be used to properly place the feeding tube assembly in the container 904 so that the proper bend is set into the image assembly 518. More particularly, the imagine assembly 518 is placed in the container 904 so that the arrow 62 may be seen through the transparent side wall of the container. In this way, the proper preformed bend will be set into the imaging assembly 518 by the container 904. The bend may, for example, facilitate passage of the imaging assembly 518 through the sharp curvature of the nasopharynx.

Further aspects of the invention can be directed to utilizing thermoplastic, thermosetting materials, or combinations or blends thereof as materials of construction of any of the components of the feeding tube assembly which provide the preferential curvilinear shape. For example, the imaging assembly can have a portion, e.g., at anterior and posterior lengthwise portions thereof and along or parallel the longitudinal axis of the feeding tube and orthogonal the fold lines of the flex circuit, comprised of a first polyurethane having a first hardness (e.g., durometer) or modulus of elasticity, and a second portion of the housing, such as longitudinal lateral portions parallel along the flex circuit planar surface, comprised of a second polyurethane having a second hardness or modulus of elasticity that is greater than that of the first polyurethane. The multicomponent housing can be made by co-extrusion or co-casting the various polyurethane compositions.

When introducing elements of aspects of the invention or the embodiments thereof, the articles “a,” “an,” “the,” and “said” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.

Having described aspects of the invention in detail, it will be apparent that modifications and variations are possible without departing from the scope of aspects of the invention as defined in the appended claims. As various changes could be made in the above constructions, products, and methods without departing from the scope of aspects of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. 

1. A feeding tube assembly having a feeding outlet for delivering enteral feeding liquid, comprising: a feeding tube having opposite first and second longitudinal ends, and a feeding passage extending along a longitudinal axis defined between the first and second longitudinal ends of the feeding tube; an imaging assembly secured to the feeding tube proximate the first longitudinal end of the feeding tube, the imaging assembly having a rigid axis and a bending axis transversely oriented relative to the rigid axis, the imaging assembly preferentially deformable along the bending axis relative to the rigid axis; and a marking disposed proximate the first longitudinal end on the feeding tube, the marking configured to provide an indication of the bending axis.
 2. (canceled)
 3. The feeding tube assembly of claim 1, wherein the imaging assembly comprises a deformable circuit element that is preferentially deformable with the bending axis relative to the rigid axis, and an imaging device mounted on the deformable circuit element.
 4. The feeding tube assembly of claim 3, wherein the imaging assembly further comprises a light source and housing enclosing the deformable circuit element, the imaging device, and the light source, wherein the marking is disposed on an outer surface of the housing.
 5. The feeding tube assembly of claim 4, wherein the deformable circuit element comprises a planar longitudinal portion oriented parallel to the longitudinal axis of the feeding tube, and a planar transverse portion transversely oriented relative to the longitudinal axis of the feeding tube, wherein the deformable circuit element is preferentially bendable along the planar longitudinal portion, and wherein the imaging device and the light source are mounted on the transverse portion of the deformable circuit element.
 6. The feeding tube assembly of claim 3, wherein the deformable circuit comprises a planar longitudinal portion and at least one fold line on the planar longitudinal portion oriented transversely relative to the longitudinal axis of the feeding tube.
 7. The feeding tube assembly of claim 1, wherein the imaging assembly has a curvilinear pre-set shape along the bending axis.
 8. A feeding tube kit comprising: a feeding tube assembly including a flexible feeding tube having opposite first and second longitudinal ends, a longitudinal axis extending between the first and second longitudinal ends, and a feeding passage defined therein extending along the longitudinal axis between the first and second longitudinal ends, an inlet adaptor adjacent the second longitudinal end of the tube in fluid communication with the feeding passage, the inlet adaptor configured for fluid connection to a source of enteral feeding liquid to fluidly connect the source of enteral feeding liquid to the feeding passage, an elongate imaging assembly including an imaging device, the imaging assembly configured for generating and transmitting imaging signals indicative of images of the alimentary canal of a subject, wherein the imaging assembly has a longitudinal axis and is secured to the tube adjacent the first longitudinal end of the tube, the imaging assembly being bendable along its longitudinal axis in a bending direction, and a feeding outlet proximate the imaging assembly and in fluid communication with the feeding passage for delivering enteral feeding liquid to the subject; and a package in which the feeding tube assembly is received, the package including a feeding tube receiving cavity, at least a portion of the feeding tube being received in the feeding tube receiving cavity, the package further including an imaging assembly cavity having an elongate, curvilinear shape selected to pre-form a desired bend into the imaging device, wherein the imaging assembly is received in the imaging assembly cavity so that the imaging assembly conforms generally to the curvilinear shape of the imaging assembly cavity and the imaging assembly cavity sets the imaging assembly in the desired bend so that the imaging assembly retains the desired bend upon removal of the feeding tube assembly from the package.
 9. The feeding tube assembly packaging of claim 8, wherein the imaging assembly cavity includes opposing, curvilinear side walls engaging the imaging assembly.
 10. The feeding tube assembly packaging of claim 9, wherein the imaging assembly is generally non-bendable along its longitudinal axis in a transverse direction that is generally transverse to the bending direction, wherein the feeding tube assembly further includes a marking on the feeding tube generally adjacent the first longitudinal end of the feeding tube, the marking configured for indicating at least one of the bending direction of the imaging assembly, the package comprising a transparent side wall, the marking being visible through the transparent side wall when the imaging assembly is received in the imaging assembly cavity to indicate that the desired bend has been properly set.
 11. The feeding tube assembly packing of claim 10, wherein the marking is aligned with the packaging to orient the imaging assembly in the imaging assembly cavity.
 12. (canceled)
 13. The feeding tube assembly packaging as set forth in claim 8, wherein the feeding tube assembly includes a marking that is aligned with the packaging so as to orient the imaging assembly in the imaging assembly cavity to pre-set a shape in the imaging assembly for traversing the nasopharynx.
 14. The feeding tube assembly packaging of claim 8, wherein the feeding tube is coiled and received in the feeding tube receiving cavity.
 15. A method of providing a feeding tube assembly having a feeding passage and a feeding outlet for delivering enteral feeding liquid, the method comprising: providing a feeding tube having an imaging assembly secured to the feeding tube proximate the feeding outlet of the feeding tube, the imaging assembly having a rigid axis and a bending axis that is transversely oriented relative to the rigid axis, wherein the imaging assembly is preferentially deformable along the bending axis relative to the rigid axis; providing a container comprising a feeding tube receiving cavity and an curvilinear cavity; disposing at least a portion of the feeding tube in the feeding tube receiving cavity; and arcuately disposing at least a portion of the imaging assembly in the curvilinear cavity in conformation with the bending axis of the imaging assembly, the curvilinear cavity setting the imaging assembly in a desired bend so that the imaging assembly retains the desired bend upon removal of the feeding tube assembly from the package.
 16. The method of claim 15, further comprising coiling at least a portion of the feeding tube in a plurality of loops, each of the loops having a coiling direction at least partially coincident the bending axis; and disposing at least one of the loops in the feeding tube receiving cavity.
 17. The method of claim 15, wherein the feeding tube assembly further comprises a marking disposed on the feeding tube, and wherein the marking is configured to provide an indication of the bending axis.
 18. The method of claim 17, further comprising disposing at least a portion of the feeding tube in the feeding tube receiving cavity such that the marking is visible through a transparent side wall of the package indicating that the desired bend has been properly set. 